Detecting severe dry eye and improving its treatment
Detection and Optimization of Treatment of Severe Cases of Dry Eye Disease
Singapore National Eye Centre · NCT07554911
We will test whether an AI tool that analyzes one corneal photo can better find adults with severe dry eye who need specialist treatment, compared with or added to a short DEQ-5 questionnaire.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | Singapore National Eye Centre (other gov) |
| Locations | 1 site (Singapore) |
| Trial ID | NCT07554911 on ClinicalTrials.gov |
What this trial studies
Investigators will use a prototype AI algorithm to analyze a single corneal photograph taken after dye staining to identify central corneal staining associated with severe dry eye. Adults previously diagnosed with dry eye will complete the DEQ-5 symptom questionnaire and undergo standardized eye examinations and corneal imaging at the Singapore Eye Research Institute. The AI results will be compared with DEQ-5 screening to see if adding or replacing the questionnaire improves identification of cases that require specialist prescription therapies such as cyclosporine. The study aims to reduce unnecessary hospital referrals and support sustainable community-based management.
Who should consider this trial
Good fit: Adults aged 21 and older previously diagnosed with dry eye at a dry eye clinic who are willing to complete eye examinations and questionnaires are the ideal candidates.
Not a fit: Patients with mild dry eye without central corneal staining, those who cannot undergo dye staining or imaging, or those with unrelated ocular comorbidities may not benefit from this AI screening.
Why it matters
Potential benefit: If successful, the AI screening could help primary care identify severe cases earlier, direct appropriate patients to specialist care faster, and reduce unnecessary referrals.
How similar studies have performed: Preliminary data from over 1,000 corneal images collected in China and Singapore suggest the prototype AI is sensitive and specific for detecting cases with central corneal staining.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 21 years old and above 2. Participants must be previously diagnosed with dry eye in the dry eye clinic (previous referred and had various forms of treatment such as artificial tears or prescription eyedrops) 3. Willing to perform all eye examinations and questionnaires in this study 4. Ability to provide informed consent Exclusion Criteria: 1. All subjects meeting any of the exclusion criteria at baseline will be excluded from participation and then list the criterion. 2. Any other specified reason as determined by clinical investigator
Where this trial is running
Singapore
- Singapore Eye Research Institute — Singapore, Singapore (RECRUITING)
Study contacts
- Principal investigator: Louis Tong — Singapore Eye Research Institute (SERI)
- Study coordinator: Sharon Yeo, BSc
- Email: sharon.yeo.w.j@singhealth.com.sg
- Phone: 65767200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.